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21 CFR Part 11

29 10, 2020

Revasum Implements AssurX Solution for Semiconductor Issue Management
Revasum Implements AssurX Solution for Semiconductor Issue Management

Revasum Implements AssurX Solution for Semiconductor Issue Management

By AssurX Blog|2020-10-29T11:22:18+00:00October 29th, 2020|Manufacturing Industries, Quality Management, Regulatory Compliance Management|

FRACAS solution will help identify platform-based issues and drive reliability p [...]

1 06, 2020

How Risk-Based Testing is Revolutionizing Computer System Validation
How Risk-Based Testing is Revolutionizing Computer System Validation

How Risk-Based Testing is Revolutionizing Computer System Validation

By AssurX Blog|2020-06-01T12:23:10+00:00June 1st, 2020|FDA Regulated Industries, Manufacturing Industries, Quality Management|

We live in a world where speed is vital to success. Patients and consumers expe [...]

19 12, 2019

Best Practices for 21 CFR Part 11 Compliance
Best Practices for 21 CFR Part 11 Compliance

Best Practices for 21 CFR Part 11 Compliance

By AssurX Blog|2019-12-19T07:00:30+00:00December 19th, 2019|Document Management, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

With more modern-day compliance enforcement, life science manufacturers and dist [...]

3 04, 2017

FDA Warning Letters Emphasize Document Control System Compliance
FDA Warning Letters Emphasize Document Control System Compliance

FDA Warning Letters Emphasize Document Control System Compliance

By AssurX Blog|2017-04-03T10:27:11+00:00April 3rd, 2017|Archives, FDA Regulated Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]

19 12, 2016

Document Management Problems Threaten Pharmaceutical Manufacturers
Document Management Problems Threaten Pharmaceutical Manufacturers

Document Management Problems Threaten Pharmaceutical Manufacturers

By AssurX Blog|2016-12-19T17:33:07+00:00December 19th, 2016|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Document management problems could soon impact the momentum in the number and sp [...]